AgingACHIEVENCT03243422
Aging and Cognitive Health Evaluation in Elders (ACHIEVE)
A study testing Successful aging health education intervention and Hearing intervention in people with Aging and Cognitive Decline, run by Johns Hopkins Bloomberg School of Public Health at 4 sites in United States.
Trial summary
The ACHIEVE study will be a randomized controlled trial nested within the infrastructure of the Atherosclerosis Risk in Communities (ARIC) study. We plan to enroll 850 70-84 year-old cognitively normal older adults with hearing loss, who will be randomized 1:1 to the hearing intervention (hearing needs assessment… Read more about this study
- Who is it for?
- Ages 70 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Cognitive Decline
- What is being tested?
- Successful aging health education intervention and Hearing intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 977 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Jan 2018to 12 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 84 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 70-84 years. Individuals aged 70-84 at the time of randomization are eligible for participation. This age range will allow recruitment of participants who are at risk for cognitive decline but who may also be expected to survive for the duration of the trial. This age range is estimated to allow for potential participation of 61% of participants currently enrolled in the ARIC study.
- Community-dwelling.
- Fluent English-speaker.
- Residency. Participants must plan to reside in the local area for the study duration.
- Audiometric hearing impairment. Participants must have adult-onset hearing impairment with a four-frequency pure tone average (0.5, 1, 2, 4 kHz) in the better-hearing ear of ≥ 30 decibels (dB) and <70 dB. This level of hearing impairment is the level at which individuals would be most likely to benefit from the use of conventional amplification devices such as hearing aids.
- Word Recognition in Quiet score ≥60% in the better ear. A word recognition in quiet score <60% suggests hearing impairment that is too severe to benefit from conventional amplification devices such as hearing aids.
- Mini-Mental State Exam (MMSE) score ≥ 23 for individuals with high-school degree or less; Mini-Mental State Exam (MMSE) score ≥ 25 for individuals with some college or more; Participants must be at risk for cognitive decline in the range quantified well by neurocognitive testing, and so must be free from more substantial cognitive impairment at baseline.
- Willingness to participate be randomized and adhere to the protocol. Participants must be willing and able to consent to participate in the study, be willing to be randomized to either the Hearing intervention or to the Successful Aging intervention, and be willing to commit to adhere to the study protocol for the duration of the trial (3 years of a randomly assigned intervention).
Who cannot join
- Self-reported disability in ≥ 2 or more Activities of Daily Living (ADL).
- Any self-reported hearing aid use in the past year. Trial participants will be randomized to hearing intervention or successful aging intervention and, therefore, participants cannot be receiving treatment for their hearing loss already.
- ARIC participants only: Diagnosis of adjudicated dementia based on a previous ARIC visit or participant required a proxy to assist with completing informed consent and responding to questions at ARIC Visit 6 or 7.
- Vision impairment (worse than 20/63 on MNREAD Acuity Chart). Participants who cannot see (with correction) well enough to complete the neurocognitive assessment are excluded.
- Medical contraindication to use of hearing aids (e.g., draining ear). Because hearing aids will be the primary device used in the hearing intervention, participants with medical contraindications to hearing aid use are excluded.
- Permanent conductive hearing impairment as determined by a difference in air audiometry and bone audiometry ("air-bone gap") greater than 15 dB in 2 or more contiguous frequencies in both ears. Because the impact of a conductive (versus a sensorineural) hearing loss on cognitive functioning may potentially differ and programming for hearing aids differs for conductive hearing loss, participants with permanent conductive hearing loss are excluded from the trial. Participants with an air-bone gap due to fluid in the ears or other resolvable medical issue may be enrolled in the trial following successful medical resolution of the cause of the air-bone gap.
- Unwilling to wear hearing aids on a regular (i.e., daily or near daily) basis.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins Comstock Center for Public Health Research
Hagerstown, Maryland, 21740
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Minnesota
Minneapolis, Minnesota, 55455
Wake Forest University
Winston-Salem, North Carolina, 27109
About this study
Official title: Aging and Cognitive Health Evaluation in Elders (ACHIEVE) Randomized Trial
The ACHIEVE study will be a randomized controlled trial nested within the infrastructure of the Atherosclerosis Risk in Communities (ARIC) study. We plan to enroll 850 70-84 year-old cognitively normal older adults with hearing loss, who will be randomized 1:1 to the hearing intervention (hearing needs assessment, fitting of hearing devices, education/counseling) or successful aging health education intervention (individual sessions with a health educator covering healthy aging topics). Post-baseline, participants will be followed semi-annually for 3 years.
Read the detailed description
The ACHIEVE study will be a randomized controlled trial nested within the infrastructure of the Atherosclerosis Risk in Communities (ARIC) study. We plan to enroll 850 70-84 year-old cognitively normal older adults with hearing loss, who will be randomized 1:1 to the hearing intervention (hearing needs assessment, fitting of hearing devices, education/counseling) or successful aging health education intervention (individual sessions with a health educator covering healthy aging topics). Post-baseline, participants will be followed semi-annually for 3 years.
Outcomes will include assessments of cognition, social functioning, physical functioning, and quality of life.
- Conditions
- Aging, Cognitive Decline
- Being tested
- Successful aging health education intervention, Hearing intervention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Successful aging health education interventionOther
The Successful Aging intervention will follow the protocol and materials developed for the 10 Keys™ to Healthy Aging program by the Center for Aging and Population Health Prevention Research Center at the University of Pittsburgh. This interactive, dynamic program informs older adults about risk factors for diseases. Participants will meet individually with a health educator certified to administer the program every 2-3 weeks for a total of 4 visits over approximately 8-10 weeks, and the session content will focus on a "Key". Each session will also include a 5-10 minute active upper body extremity stretching program as used in the Lifestyle Interventions and Independence for Elders (LIFE) study. Participants will return for booster sessions semi-annually beginning at 6 months post-randomization.
Hearing interventionOther
The hearing intervention consists of fitting with hearing aids and other hearing assistive technologies plus four 1-hour comprehensive, individualized hearing rehabilitation sessions spaced over the 2-3 months post-randomization designed to provide all of the active components of the intervention. Hearing aids are instructed to be worn on a daily basis for study duration. Audiologic outcomes (e.g., hearing aid data logging, real ear measures, speech in noise, etc.) to verify the best-practices hearing intervention are gathered during study intervention visits and semi-annually beginning at 6 months post-randomization.
| Study group | Role | What they receive |
|---|---|---|
| Successful aging health education intervention | Active comparator | Individual sessions on healthy aging topics Receives: Other: Successful aging health education intervention |
| Hearing intervention | Active comparator | Best practices hearing rehabilitative treatment Receives: Other: Hearing intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Global Cognitive Function
Mean change in global cognitive function in standard deviations from baseline to year 3 estimated from a linear mixed-effects model. Global cognitive function was defined as a factor score derived from the completion of a neurocognitive testing battery. The ACHIEVE study administers a neurocognitive testing battery annually, which includes the following cognitive tests: Delayed Word Recall, Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Word List, Incidental Learning, Logical Memory I and II, Word Fluency, Animal Naming, Boston Naming, Trail Making Test A and B, Digit Span Backwards, and Digit Symbol Substitution. Factor analytic methods use all items from all tests in the battery to generate a single score of global cognitive function. The global cognitive function factor score has a minimum of -5 and a maximum of 4. Lower scores denote worse cognitive function.
Measured: 3 years
Secondary outcomes (4)
Change in Cognition Memory Domain
Mean change in cognition memory domain in standard deviations from baseline to year 3 estimated from a linear mixed-effects model. The cognition memory domain was defined as a factor score derived from the completion of a neurocognitive testing battery. The cognitive tests for the memory domain include Delayed Word Recall, CERAD Word List, Incidental Learning, and Logical Memory I and II. These tests have an underlying commonality or factor, that is unable to be directly measured, and factor analytic methods use items from the tests noted to generate a single overall memory score. The cognition memory domain factor score has a minimum of -5 and a maximum of 4. Lower scores denote worse cognitive function.
Measured: 3 years
Change in Cognition Executive Function Domain
Mean change in cognitive executive function in standard deviations from baseline to year 3 estimated from a linear mixed-effects model. The executive function domain was defined as a factor score derived from the completion of a neurocognitive testing battery. The cognitive tests for the executive function domain include Trail Making Test A and B and Digit Symbol Substitution. These tests have an underlying commonality or factor, that is unable to be directly measured, and factor analytic methods use items from the tests noted to generate a single overall executive function score. The executive function cognitive factor score has a minimum of -5 and a maximum of 4. Lower scores denote worse cognitive function.
Measured: 3 years
Change in Cognition Language Domain
Mean change in cognition language domain in standard deviations from baseline to year 3 estimated from a linear mixed-effects model. The cognition language domain as defined as a factor score derived from the completion of a neurocognitive testing battery. The cognitive tests for the language domain include Word Fluency, Animal Naming, and Boston Naming. These tests have an underlying commonality or factor, that is unable to be directly measured, and factor analytic methods use items from the tests noted to generate a single overall language score. The cognition language domain factor score has a minimum of -5 and a maximum of 4. Lower scores denote worse cognitive function.
Measured: 3 years
Number of Participants Who Developed Cognitive Impairment
Incident cognitive impairment with the outcome defined as the first instance of (1) adjudicated diagnosis of dementia or mild cognitive impairment (MCI), (2) 3-point drop in the 30-item Mini-Mental State Exam (MMSE) administered in-person, or (3) a 3-point drop in a factor score derived from the 10-item MMSE orientation subscale and 11-item Blessed scale administered over the telephone and rescaled to be equivalent to the 30-item MMSE. The numbers below in the outcome measure data table represent the number of cases (participants) who developed cognitive impairment, within 3 years.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start4 Jan 2018
- Primary completion30 Nov 2022
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 977 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, University of South Florida, University of Pittsburgh, University of Mississippi Medical Center, Wake Forest University, University of Minnesota, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Frank R Lin, MD, PhD, Principal investigator, Johns Hopkins UniversityJosef Coresh, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243422
- Sponsor's protocol ID
- IRB00008129
- Other IDs
- R01AG055426
- Acronym
- ACHIEVE
- Status last verified
- Jan 2024
- First submitted
- 27 Jul 2017
- Last updated
- 1 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pike JR, Huang AR, Reed N, Arnold ML, Chisolm TH, Couper D, Deal JA, Faucette S, Goman AM, Gottesman RF, Hughes TM, Knopman D, Mitchell C, Mosley TH, Palta P, Pankow JS, Sanchez VA, Selvin E, Sullivan KJ, Thyagarajan B, Wagenknecht LE, Lin FR, Coresh J; ACHIEVE Collaborative Research Groups; ACHIEVE Collaborative Research Group. Effects of hearing intervention on blood-based biomarkers of neuroinflammation and neurodegeneration: a secondary analysis of the ACHIEVE randomised controlled trial. EClinicalMedicine. 2026 Sep 3;99:104164. doi: 10.1016/j.eclinm.2026.104164. eCollection 2026 Sep.
PubMed 42733779Deal JA, Zhang W, Jiang K, Huang A, Pike JR, Arnold M, Burgard S, Chen ZS, Chisolm T, Couper D, Goman AM, Glynn NW, Gmelin T, Gravens-Mueller L, Hayden KM, Mitchell CM, Pankow JS, Reed NS, Sanchez V, Schrack JA, Sullivan K, Lin FR, Coresh J; ACHIEVE Collaborative Research Group. Effects of hearing intervention on physical function: A secondary analysis of the ACHIEVE study. PLoS One. 2026 Apr 29;21(4):e0347500. doi: 10.1371/journal.pone.0347500. eCollection 2026.
PubMed 42054408Sanchez VA, Garcia Morales EE, Arnold ML, Neil Calloway HN, Faucette S, Goman AM, Huang AR, Mitchell CM, Reed NS, Sherry L, Weycker JM, Chisolm TH. Patient-Centered Hearing Intervention Leads to Positive Outcomes: The Association of Hearing Technology With Daily Hearing Aid Usage and Listening Goals in the Aging and Cognitive Health Evaluation in Elders Study. Am J Audiol. 2026 Jun 2;35(2):634-651. doi: 10.1044/2026_AJA-25-00229. Epub 2026 Apr 27.
PubMed 42044054Goman AM, Tan N, Pike JR, Bessen SY, Chen ZS, Huang AR, Arnold ML, Burgard S, Chisolm TH, Couper D, Deal JA, Glynn NW, Gmelin T, Gravens-Mueller L, Hayden KM, Martinez-Amezcua P, Mitchell CM, Pankow JS, Reed NS, Sanchez VA, Schrack JA, Sullivan KJ, Coresh J, Lin FR; ACHIEVE Collaborative Research Group. Effects of hearing intervention on falls in older adults: findings from a secondary analysis of the ACHIEVE randomised controlled trial. Lancet Public Health. 2025 Jun;10(6):e492-e502. doi: 10.1016/S2468-2667(25)00088-X.
PubMed 40441816Pike JR, Huang AR, Reed NS, Arnold M, Chisolm T, Couper D, Deal JA, Glynn NW, Goman AM, Hayden KM, Mitchell CM, Pankow JS, Sanchez V, Sullivan KJ, Tan NS, Coresh J, Lin FR; ACHIEVE Collaborative Research Group. Cognitive benefits of hearing intervention vary by risk of cognitive decline: A secondary analysis of the ACHIEVE trial. Alzheimers Dement. 2025 May;21(5):e70156. doi: 10.1002/alz.70156.
PubMed 40369891Reed NS, Chen J, Huang AR, Pike JR, Arnold M, Burgard S, Chen Z, Chisolm T, Couper D, Cudjoe TKM, Deal JA, Goman AM, Glynn NW, Gmelin T, Gravens-Mueller L, Hayden KM, Mitchell CM, Mosley T, Oh ES, Pankow JS, Sanchez VA, Schrack JA, Coresh J, Lin FR; ACHIEVE Collaborative Research Group. Hearing Intervention, Social Isolation, and Loneliness: A Secondary Analysis of the ACHIEVE Randomized Clinical Trial. JAMA Intern Med. 2025 Jul 1;185(7):797-806. doi: 10.1001/jamainternmed.2025.1140.
PubMed 40354063Huang AR, Morales EG, Arnold ML, Burgard S, Couper D, Deal JA, Glynn NW, Gmelin T, Goman AM, Gravens-Mueller L, Hayden KM, Mitchell CM, Pankow JS, Pike JR, Reed NS, Sanchez VA, Schrack JA, Sullivan KJ, Coresh J, Lin FR, Chisolm TH; ACHIEVE Collaborative Research Group. A Hearing Intervention and Health-Related Quality of Life in Older Adults: A Secondary Analysis of the ACHIEVE Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2446591. doi: 10.1001/jamanetworkopen.2024.46591.
PubMed 39570588Lin FR, Pike JR, Albert MS, Arnold M, Burgard S, Chisolm T, Couper D, Deal JA, Goman AM, Glynn NW, Gmelin T, Gravens-Mueller L, Hayden KM, Huang AR, Knopman D, Mitchell CM, Mosley T, Pankow JS, Reed NS, Sanchez V, Schrack JA, Windham BG, Coresh J; ACHIEVE Collaborative Research Group. Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial. Lancet. 2023 Sep 2;402(10404):786-797. doi: 10.1016/S0140-6736(23)01406-X. Epub 2023 Jul 18.
PubMed 37478886Sanchez VA, Arnold ML, Reed NS, Oree PH, Matthews CR, Clock Eddins A, Lin FR, Chisolm TH. The Hearing Intervention for the Aging and Cognitive Health Evaluation in Elders Randomized Control Trial: Manualization and Feasibility Study. Ear Hear. 2020 Sep/Oct;41(5):1333-1348. doi: 10.1097/AUD.0000000000000858.
PubMed 32251012Deal JA, Goman AM, Albert MS, Arnold ML, Burgard S, Chisolm T, Couper D, Glynn NW, Gmelin T, Hayden KM, Mosley T, Pankow JS, Reed N, Sanchez VA, Richey Sharrett A, Thomas SD, Coresh J, Lin FR. Hearing treatment for reducing cognitive decline: Design and methods of the Aging and Cognitive Health Evaluation in Elders randomized controlled trial. Alzheimers Dement (N Y). 2018 Oct 5;4:499-507. doi: 10.1016/j.trci.2018.08.007. eCollection 2018.
PubMed 30364572
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging and Cognitive Health Evaluation in Elders (ACHIEVE) Randomized Trial
- ClinicalTrials.gov ID
- NCT03243422
- Acronym / sponsor ID
- ACHIEVE / IRB00008129
- Conditions
- Aging, Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 977 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- University of North Carolina, University of South Florida, University of Pittsburgh, University of Mississippi Medical Center, Wake Forest University, University of Minnesota, National Institute on Aging (NIA)
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Posted 1 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ACHIEVE study will be a randomized controlled trial nested within the infrastructure of the Atherosclerosis Risk in Communities (ARIC) study. We plan to enroll 850 70-84 year-old cognitively normal older adults with hearing loss, who will be randomized 1:1 to the hearing intervention (hearing needs assessment, fitting of hearing devices, education/counseling) or successful aging health education intervention (individual sessions with a health educator covering healthy aging topics). Post-baseline, participants will be followed semi-annually for 3 years.
Detailed description
The ACHIEVE study will be a randomized controlled trial nested within the infrastructure of the Atherosclerosis Risk in Communities (ARIC) study. We plan to enroll 850 70-84 year-old cognitively normal older adults with hearing loss, who will be randomized 1:1 to the hearing intervention (hearing needs assessment, fitting of hearing devices, education/counseling) or successful aging health education intervention (individual sessions with a health educator covering healthy aging topics). Post-baseline, participants will be followed semi-annually for 3 years.
Outcomes will include assessments of cognition, social functioning, physical functioning, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successful aging health education intervention | Active comparator | Other: Successful aging health education interventionIndividual sessions on healthy aging topics |
| Hearing intervention | Active comparator | Other: Hearing interventionBest practices hearing rehabilitative treatment |
Who may qualify
- Ages
- 70 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Age 70-84 years. Individuals aged 70-84 at the time of randomization are eligible for participation. This age range will allow recruitment of participants who are at risk for cognitive decline but who may also be expected to survive for the duration of the trial. This age range is estimated to allow for potential participation of 61% of participants currently enrolled in the ARIC study.
- Community-dwelling.
- Fluent English-speaker.
- Residency. Participants must plan to reside in the local area for the study duration.
- Audiometric hearing impairment. Participants must have adult-onset hearing impairment with a four-frequency pure tone average (0.5, 1, 2, 4 kHz) in the better-hearing ear of ≥ 30 decibels (dB) and <70 dB. This level of hearing impairment is the level at which individuals would be most likely to benefit from the use of conventional amplification devices such as hearing aids.
Key exclusion criteria (7 listed)
- Self-reported disability in ≥ 2 or more Activities of Daily Living (ADL).
- Any self-reported hearing aid use in the past year. Trial participants will be randomized to hearing intervention or successful aging intervention and, therefore, participants cannot be receiving treatment for their hearing loss already.
- ARIC participants only: Diagnosis of adjudicated dementia based on a previous ARIC visit or participant required a proxy to assist with completing informed consent and responding to questions at ARIC Visit 6 or 7.
- Vision impairment (worse than 20/63 on MNREAD Acuity Chart). Participants who cannot see (with correction) well enough to complete the neurocognitive assessment are excluded.
- Medical contraindication to use of hearing aids (e.g., draining ear). Because hearing aids will be the primary device used in the hearing intervention, participants with medical contraindications to hearing aid use are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Successful aging health education interventionThe Successful Aging intervention will follow the protocol and materials developed for the 10 Keys™ to Healthy Aging program by the Center for Aging and Population Health Prevention Research Center at the University of Pittsburgh. This interactive, dynamic program informs older adults about risk factors for diseases. Participants will meet individually with a health educator certified to administer the program every 2-3 weeks for a total of 4 visits over approximately 8-10 weeks, and the session content will focus on a "Key". Each session will also include a 5-10 minute active upper body extremity stretching program as used in the Lifestyle Interventions and Independence for Elders (LIFE) study. Participants will return for booster sessions semi-annually beginning at 6 months post-randomization. | Other | Successful aging health education intervention |
| Hearing interventionThe hearing intervention consists of fitting with hearing aids and other hearing assistive technologies plus four 1-hour comprehensive, individualized hearing rehabilitation sessions spaced over the 2-3 months post-randomization designed to provide all of the active components of the intervention. Hearing aids are instructed to be worn on a daily basis for study duration. Audiologic outcomes (e.g., hearing aid data logging, real ear measures, speech in noise, etc.) to verify the best-practices hearing intervention are gathered during study intervention visits and semi-annually beginning at 6 months post-randomization. | Other | Hearing intervention |
Primary outcome
Change in Global Cognitive Function
Time frame: 3 years
Mean change in global cognitive function in standard deviations from baseline to year 3 estimated from a linear mixed-effects model. Global cognitive function was defined as a factor score derived from the completion of a neurocognitive testing battery. The ACHIEVE study administers a neurocognitive testing battery annually, which includes the following cognitive tests: Delayed Word Recall, Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Word List, Incidental Learning, Logical Memory I and II, Word Fluency, Animal Naming, Boston Naming, Trail Making Test A and B, Digit Span Backwards, and Digit Symbol Substitution. Factor analytic methods use all items from all tests in the battery to generate a single score of global cognitive function. The global cognitive function factor score has a minimum of -5 and a maximum of 4. Lower scores denote worse cognitive function.
4 secondary outcomes
Change in Cognition Memory Domain
Time frame: 3 years
Change in Cognition Executive Function Domain
Time frame: 3 years
Change in Cognition Language Domain
Time frame: 3 years
Number of Participants Who Developed Cognitive Impairment
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42733779Pike JR, Huang AR, Reed N, Arnold ML, Chisolm TH, Couper D, Deal JA, Faucette S, Goman AM, Gottesman RF, Hughes TM, Knopman D, Mitchell C, Mosley TH, Palta P, Pankow JS, Sanchez VA, Selvin E, Sullivan KJ, Thyagarajan B, Wagenknecht LE, Lin FR, Coresh J; ACHIEVE Collaborative Research Groups; ACHIEVE Collaborative Research Group. Effects of hearing intervention on blood-based biomarkers of neuroinflammation and neurodegeneration: a secondary analysis of the ACHIEVE randomised controlled trial. EClinicalMedicine. 2026 Sep 3;99:104164. doi: 10.1016/j.eclinm.2026.104164. eCollection 2026 Sep.
- Derived from this study: PubMed 42054408Deal JA, Zhang W, Jiang K, Huang A, Pike JR, Arnold M, Burgard S, Chen ZS, Chisolm T, Couper D, Goman AM, Glynn NW, Gmelin T, Gravens-Mueller L, Hayden KM, Mitchell CM, Pankow JS, Reed NS, Sanchez V, Schrack JA, Sullivan K, Lin FR, Coresh J; ACHIEVE Collaborative Research Group. Effects of hearing intervention on physical function: A secondary analysis of the ACHIEVE study. PLoS One. 2026 Apr 29;21(4):e0347500. doi: 10.1371/journal.pone.0347500. eCollection 2026.
- Derived from this study: PubMed 42044054Sanchez VA, Garcia Morales EE, Arnold ML, Neil Calloway HN, Faucette S, Goman AM, Huang AR, Mitchell CM, Reed NS, Sherry L, Weycker JM, Chisolm TH. Patient-Centered Hearing Intervention Leads to Positive Outcomes: The Association of Hearing Technology With Daily Hearing Aid Usage and Listening Goals in the Aging and Cognitive Health Evaluation in Elders Study. Am J Audiol. 2026 Jun 2;35(2):634-651. doi: 10.1044/2026_AJA-25-00229. Epub 2026 Apr 27.
- Derived from this study: PubMed 40441816Goman AM, Tan N, Pike JR, Bessen SY, Chen ZS, Huang AR, Arnold ML, Burgard S, Chisolm TH, Couper D, Deal JA, Glynn NW, Gmelin T, Gravens-Mueller L, Hayden KM, Martinez-Amezcua P, Mitchell CM, Pankow JS, Reed NS, Sanchez VA, Schrack JA, Sullivan KJ, Coresh J, Lin FR; ACHIEVE Collaborative Research Group. Effects of hearing intervention on falls in older adults: findings from a secondary analysis of the ACHIEVE randomised controlled trial. Lancet Public Health. 2025 Jun;10(6):e492-e502. doi: 10.1016/S2468-2667(25)00088-X.
- Derived from this study: PubMed 40369891Pike JR, Huang AR, Reed NS, Arnold M, Chisolm T, Couper D, Deal JA, Glynn NW, Goman AM, Hayden KM, Mitchell CM, Pankow JS, Sanchez V, Sullivan KJ, Tan NS, Coresh J, Lin FR; ACHIEVE Collaborative Research Group. Cognitive benefits of hearing intervention vary by risk of cognitive decline: A secondary analysis of the ACHIEVE trial. Alzheimers Dement. 2025 May;21(5):e70156. doi: 10.1002/alz.70156.
- Derived from this study: PubMed 40354063Reed NS, Chen J, Huang AR, Pike JR, Arnold M, Burgard S, Chen Z, Chisolm T, Couper D, Cudjoe TKM, Deal JA, Goman AM, Glynn NW, Gmelin T, Gravens-Mueller L, Hayden KM, Mitchell CM, Mosley T, Oh ES, Pankow JS, Sanchez VA, Schrack JA, Coresh J, Lin FR; ACHIEVE Collaborative Research Group. Hearing Intervention, Social Isolation, and Loneliness: A Secondary Analysis of the ACHIEVE Randomized Clinical Trial. JAMA Intern Med. 2025 Jul 1;185(7):797-806. doi: 10.1001/jamainternmed.2025.1140.
- Derived from this study: PubMed 39570588Huang AR, Morales EG, Arnold ML, Burgard S, Couper D, Deal JA, Glynn NW, Gmelin T, Goman AM, Gravens-Mueller L, Hayden KM, Mitchell CM, Pankow JS, Pike JR, Reed NS, Sanchez VA, Schrack JA, Sullivan KJ, Coresh J, Lin FR, Chisolm TH; ACHIEVE Collaborative Research Group. A Hearing Intervention and Health-Related Quality of Life in Older Adults: A Secondary Analysis of the ACHIEVE Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2446591. doi: 10.1001/jamanetworkopen.2024.46591.
- Derived from this study: PubMed 37478886Lin FR, Pike JR, Albert MS, Arnold M, Burgard S, Chisolm T, Couper D, Deal JA, Goman AM, Glynn NW, Gmelin T, Gravens-Mueller L, Hayden KM, Huang AR, Knopman D, Mitchell CM, Mosley T, Pankow JS, Reed NS, Sanchez V, Schrack JA, Windham BG, Coresh J; ACHIEVE Collaborative Research Group. Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial. Lancet. 2023 Sep 2;402(10404):786-797. doi: 10.1016/S0140-6736(23)01406-X. Epub 2023 Jul 18.
- Derived from this study: PubMed 32251012Sanchez VA, Arnold ML, Reed NS, Oree PH, Matthews CR, Clock Eddins A, Lin FR, Chisolm TH. The Hearing Intervention for the Aging and Cognitive Health Evaluation in Elders Randomized Control Trial: Manualization and Feasibility Study. Ear Hear. 2020 Sep/Oct;41(5):1333-1348. doi: 10.1097/AUD.0000000000000858.
- Derived from this study: PubMed 30364572Deal JA, Goman AM, Albert MS, Arnold ML, Burgard S, Chisolm T, Couper D, Glynn NW, Gmelin T, Hayden KM, Mosley T, Pankow JS, Reed N, Sanchez VA, Richey Sharrett A, Thomas SD, Coresh J, Lin FR. Hearing treatment for reducing cognitive decline: Design and methods of the Aging and Cognitive Health Evaluation in Elders randomized controlled trial. Alzheimers Dement (N Y). 2018 Oct 5;4:499-507. doi: 10.1016/j.trci.2018.08.007. eCollection 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank R Lin, MD, PhD principal investigator
Johns Hopkins University
Josef Coresh principal investigator
Johns Hopkins University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Successful aging health education intervention and Hearing intervention in people with Aging and Cognitive Decline, run by Johns Hopkins Bloomberg School of Public Health at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Global Cognitive Function (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03243422, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.